Happiest Baby, Inc is voluntarily issuing a recall of its extra-small (XS) and extra-large (XL) SNOO Sacks^® that were purchased in the U.S.

Reason for this recall:

This action follows communication from the U.S. Food and Drug Administration (FDA) advising Happiest Baby that the XS and XL SNOO Sacks were not reviewed for safety and effectiveness by the FDA and have not received the required FDA premarket authorization.

Potential risk to health:

Extra-Small

The XS SNOO Sack is similar to the FDA authorized small SNOO Sack, but it is ¾” narrower and 2” shorter.

The FDA stated that the change in dimensions could potentially result in a fit being too tight. To date, Happiest Baby has not received any reports of injury in connection with the use of the XS SNOO Sacks.

Extra-Large

The XL SNOO Sack is similar to the FDA authorized large SNOO Sack, but ½” wider and 3” longer.

The FDA stated that the change in dimensions could potentially result in the sack bunching up at the top, towards the baby’s face, or make it easier for a smaller baby to break free inside the sack. To date, Happiest Baby has not received any reports of injury in connection with the use of the XL SNOO Sacks.

How to recognize if your SNOO Sack does not fit properly:

Extra-Small

A fit that is excessively tight would be noticeable at the time of dressing. The sack would be difficult to zip fully closed.

Extra-Large

An oversized fit is noticeable at the time of dressing the baby: the sack would sit loosely around the chest or bunch up at the top.

Actions to be taken by users:

• Please discontinue use of your XS and/or XL SNOO Sack(s) and discard it. (If you gave anyone an XS or XL SNOO Sack, please share this letter to inform them of these important recall instructions.)
• Note: To avoid confusion, please know that this recall does not include the XS or XL size Sleepea® swaddle sacks. (Sleepea sacks have no wings and are only designed for use outside of a SNOO.)
• If you purchased an XS or XL SNOO Sack in the U.S., directly from Happiest Baby, and would like a refund or exchange for a small, medium, or large SNOO Sack, please visit https://www.happiestbaby.com/xs-xl-support for further instructions.
• If you purchased an XL SNOO Sack through Amazon, please contact Amazon directly for next steps (888-280-4331).

If you have further questions, please contact Happiest Baby Customer Care at https://www.happiestbaby.com/contactus.

Any adverse reaction or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program using one of the following options: Online: Submit the report at https://www.accessdata.fda.gov/scripts/medwatch. Or users may also reach out to the Agency by regular mail or Fax: Download the form from https://www.fda.gov/MedWatch/getforms.htm or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form or submit by fax to 800-332-0178.

Sincerely,

The Happiest Baby Team